CHAPTER IIU.K.COMPOSITION

SECTION 1U.K.[F1Authorised substances]

Article 5U.K.[F2Requirement for authorisation]

[F31.Only substances that are authorised by the appropriate authority in accordance with the procedure in Regulation (EC) No 1935/2004 may be used in components of active and intelligent materials and articles.]

2.By way of derogation from paragraph 1, the following substances may be used in components of active and intelligent materials and articles without being [F4authorised]:

(a)released active substances provided that they comply with the conditions set out in Article 9;

(b)substances falling within the scope of [F5[F6assimilated] law or any other enactment] provisions applicable to food, which are added to or incorporated into active materials and articles by techniques such as grafting or immobilisation in order to have a technological effect in the food, provided that they comply with the conditions set out in Article 9;

(c)substances used in components which are not in direct contact with food or the environment surrounding the food and are separated from the food by a functional barrier provided that they comply with the conditions set out in Article 10 and that they do not fall within either of the following categories:

(i)

substances classified as ‘mutagenic’, ‘carcinogenic’, or ‘toxic to reproduction’ in accordance with the criteria set out in sections 3.5, 3.6 and 3.7 of Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council(1);

(ii)

substances deliberately engineered to particle size which exhibit functional physical and chemical properties that significantly differ from those at a larger scale.

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Article 6U.K.Conditions for [F7authorisation]

In order to be [F8authorised], substances which constitute the components of active and intelligent materials and articles must satisfy the requirements of Article 3 and, where they apply, Article 4 of Regulation (EC) No 1935/2004 for the intended condition of use of the active or intelligent material or article.

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Article 7U.K.Content of [F9an authorisation]

[F10An authorisation] shall specify:

(a)

the identity of the substance(s);

(b)

the function of the substance(s);

(c)

the reference number;

(d)

if necessary, the conditions of use of the substance(s) or component;

(e)

if necessary, restrictions and/or specifications of use of the substance(s);

(f)

if necessary, conditions of use of the material or article to which the substance or component is added or into which it is incorporated.

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F11Article 8U.K.Conditions for the establishment of the list

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[F11Article 8AU.K.Registered substances

1.The Food Safety Authority may ask a person (“the applicant”) who applied for a registered substance to be entered in the Register to provide, within a specified period, such supplementary information or additional data as the Food Safety Authority considers necessary to evaluate that substance for the purpose of delivering its opinion to the appropriate authority prior to the determination of the authorisation status of that substance.

2.The Food Safety Authority may extend the period of time described in paragraph 1.

3.Where the Food Safety Authority makes a request under paragraph 1 and the applicant fails to provide the information or data requested within the specified period (including any extension of that period), the substance shall cease to be treated as a registered substance after the end of the day on which the applicant was required to provide the requested information but failed to do so.

4.Before determining the authorisation status of all registered substances (which, under Article 14, would cause Article 4(e) and 5 to begin to apply), the appropriate authority must:

(a)have regard to substances (“unregistered substances”) other than registered substances lawfully placed on the market; and

(b)consider the time that may reasonably be needed by a person to apply for an unregistered substance to be authorised in accordance with Regulation (EC) No 1935/2004 and this Regulation.

Textual Amendments

Article 8BU.K.Determination of authorisation status: registered substances

1.For the purposes of Article 8A, determining the authorisation status of a registered substance is to consist of the appropriate authority determining whether the registered substance is:

(a)to be authorised for placing on the market or for use in contact with food;

(b)to cease to be permitted to be placed on the market or used in contact with food, and to cease to be a registered substance.

2.A determination of a type falling within paragraph 1(b) may specify a period of time, or different periods of time, within which:

(a)existing stocks of the registered substance concerned, and any products derived from it or containing it, may be placed on the market or used;

(b)the registered substance concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used;

(c)the labelling of the registered substance concerned, and any products derived from it or containing it, may continue to be applied.

3.Where the appropriate authority makes a determination as to the authorisation status of a registered substance, the appropriate authority must:

(a)in the event of a determination to authorise the substance, specify the date on which the authorisation is to have effect; and

(b)communicate the determination to the Food Safety Authority.]

Textual Amendments

Textual Amendments

SECTION 2U.K.Conditions of use for substances [F12referred to in Article 5(2)]

Article 9U.K.Substances referred to in Article 5(2)(a) and (b)

1.Released active substances, as referred to in Article 5(2)(a) of this Regulation and substances added or incorporated by techniques such as grafting or immobilisation, as referred to in Article 5(2)(b) of this Regulation, shall be used in full compliance with [F13[F14assimilated] law and any other enactment] applicable to food, and shall comply with the provisions of Regulation (EC) No 1935/2004 and, when applicable, its implementing measures.

2.The amount of a released active substance shall not be included in the value of the measured overall migration, in cases where an overall migration limit (OML) is established in a specific F15... measure for the food contact material in which the component is incorporated.

3.Without prejudice to Article 4(1) and (3) of Regulation (EC) No 1935/2004, the amount of a released active substance may exceed the specific restriction established for that substance in [F16[F14assimilated] law or any other enactment relating to] the food contact materials in which the component is incorporated provided it complies with the [F17[F14assimilated] law] applicable to food, or, where no such provisions exist, with the national provisions applicable to food.

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Article 10U.K.Substances referred to in Article 5(2)(c)

1.The migration into food of the substances from components which are not in direct contact with food or the environment surrounding the food, as referred to in Article 5(2)(c) of this Regulation, shall not exceed 0,01 mg/kg, measured with statistical certainty by a method of analysis in accordance with Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council(2).

2.The limit provided for in paragraph 1 shall always be expressed as a concentration in foods. It shall apply to a group of substances, if they are structurally and toxicologically related, in particular isomers or substances with the same relevant functional group, and shall include possible set-off transfer.

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